US5834448A - Dosage form of hydroxocobalamin and its use in cyanide poisoning - Google Patents
Dosage form of hydroxocobalamin and its use in cyanide poisoning Download PDFInfo
- Publication number
- US5834448A US5834448A US08/748,790 US74879096A US5834448A US 5834448 A US5834448 A US 5834448A US 74879096 A US74879096 A US 74879096A US 5834448 A US5834448 A US 5834448A
- Authority
- US
- United States
- Prior art keywords
- hydroxocobalamin
- freeze
- solution
- dried
- acidic medium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Abstract
Description
______________________________________ a) Hydroxocobalamine base 0.250 g Sodium acetate 0.540 g buffer pH = 4.6 Acetic acid 0.240 g Water for injection qs 10.000 ml b) Hydroxocobalamine base 0.250 g Sodium acetate 0.188 g Sodium chloride 0.041 g Acetic acid 0.041 g Water for injection qs 10.000 ml c) Hydroxocobalamine base 0.250 g HCl 0.1N qs pH = 4.0 Water for injection qs 10.000 ml d) Hydroxocobalamine base 0.250 g HCl 0.1N qs pH = 5.0 Water for injection qs 10.000 mL e) Hydroxocobalamine base 0.250 g Sodium acetate 0.166 g Sodium chloride 0.041 g Acetic acid qs pH = 4.0 Water for injection qs 10.000 ml ______________________________________
______________________________________ f) Hydroxocobalamine base 0.250 g Arginine hydrochloride 0.010 g Water for injection qs 10.000 ml g) Hydroxocobalamine base 0.250 g Lactose 0.033 g Water for injection qs 10.000 ml h) Hydroxocobalamine base 0.250 g Glycine 0.033 g Water for injection qs 10.000 ml ______________________________________
______________________________________ Hydroxocobalamine base .sup. 2.5 g HCl 0.1N qs pH = 4.0 Water for injection qs 100.0 ml ______________________________________
TABLE 1 __________________________________________________________________________ ASSAY OF HYDROXOCOBALAMIN AND RELATED SUBSTANCES AFTER RECONSTITUTION EXPOSURE TO DAYLIGHT RRT T0 T 2H T 4H T 6H T 8H __________________________________________________________________________ RT control 100% AREAS 9.108 0.45 57616 58786 59985 54130 58406 59531 10.883 0.54 66134 64167 69257 63020 68001 70589 11.882 0.59 23607 37327 49821 38212 46438 44820 13.735 0.68 20859 14089 20064 10884 16572 17123 16.388 0.82 16894 20932 29809 22837 NI 25952 17.725 0.88 179243 220728 224772 243506 299941 276644 20.052 1.00 18379040 18341948 18863300 17675508 18279040 18168326 26.043 1.30 29265 49659 30579 50000 61549 45724 38.49 1.92 9212 151908 215684 205421 194838 190731 53.145 2.65 26971 27447 22015 41413 sum Ai 402830 617596 726942 715456 767760 77252 control TW 61.65 mg T % sec 100.8 batch 57917 c 1.022 mg/ml H % 17.8 control A= 930847 T% as 82.8576 5% such AM (g) 2.656 2.656 2.656 2.656 2.656 % 0.45 0.32 0.32 0.33 0.30 0.32 0.33 rela- 0.54 0.36 0.35 0.38 0.35 0.37 0.39 ted 0.59 0.13 0.20 0.27 0.21 0.25 0.25 sub- 0.68 0.11 0.08 0.11 0.06 0.09 0.09 stan- 0.82 0.09 0.11 0.16 0.13 * 0.14 ces 0.88 0.98 1.21 1.23 1.34 1.65 1.52 1.00 1.30 0.16 0.27 0.17 0.27 0.34 0.25 1.92 0.05 0.83 1.18 1.13 1.07 1.05 2.65 0.00 0.00 0.15 0.15 0.12 0.25 related substances 2.21 3.39 3.99 3.93 4.21 4.24 (%): % hydroxocobalamin relative to 100.0% 102.8% 96.4% 99.7% 99.1% T0 __________________________________________________________________________ NI: not integrated *taken into account in the peak of RRT 0.88
TABLE 2 __________________________________________________________________________ ASSAY OF HYDROXOCOBALAMIN AND RELATED SUBSTANCES AFTER RECONSTITUTION EXPOSURE UNDER UV LAMP AT 366 nm control RRT 100% T0 T 1H T 3H T 5H __________________________________________________________________________ RT AREAS 9.423 0.43 58375 61403 57524 59669 61494 11.38 0.52 62877 71503 66314 69342 69934 12.423 0.57 29963 47572 46343 42826 34806 14.49 0.67 24104 23374 18195 12293 9748 17.425 0.80 27503 27183 39478 38154 42460 18.797 0.87 172368 220359 207299 233187 275029 21.715 1.00 18203892 18167878 17683928 18236596 18135146 29.758 1.32 25323 28171 76643 32907 72284 43.808 2.02 7027 179220 212275 207668 212788 60.277 2.78 24889 36611 52788 sum A1 407540 658785 748960 732657 831331 control TW 61.65 mg T % sec 100.8 batch 57917 c 1.022 mg/ml H % 17.8 control S≈ 951271 T % as 82.8576 5% such AM (g) 2.656 2.656 2.656 2.656 % 0.43 0.31 0.33 0.31 0.32 0.33 rela- 0.52 0.34 0.38 0.36 0.37 0.38 ted 0.57 0.16 0.26 0.25 0.23 0.19 sub- 0.67 0.13 0.13 0.10 0.07 0.05 stan- 0.80 0.15 0.15 0.21 0.20 0.23 ces 0.87 0.93 1.18 1.11 1.25 1.48 1.00 1.32 0.14 0.15 0.41 0.18 0.39 2.02 0.04 0.96 1.14 1.12 1.14 2.78 0.00 0.00 0.13 0.20 0.28 related substances (%): 2.19 3.54 4.02 3.93 4.46 % hydroxocobalamin relative to T0 100.0% 97.3% 100.4% 99.8% __________________________________________________________________________
Claims (17)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR9513512A FR2740973B1 (en) | 1995-11-15 | 1995-11-15 | NOVEL FORM OF HYDROXOCOBALAMINE ADMINISTRATION AND ITS USE IN CYANIDE POISONING |
FR9513512 | 1995-11-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
US5834448A true US5834448A (en) | 1998-11-10 |
Family
ID=9484577
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/748,790 Expired - Lifetime US5834448A (en) | 1995-11-15 | 1996-11-14 | Dosage form of hydroxocobalamin and its use in cyanide poisoning |
Country Status (10)
Country | Link |
---|---|
US (1) | US5834448A (en) |
EP (1) | EP0775485B1 (en) |
JP (1) | JP3699223B2 (en) |
AU (1) | AU720219B2 (en) |
DE (1) | DE69619767T2 (en) |
DK (1) | DK0775485T3 (en) |
ES (1) | ES2171591T3 (en) |
FR (1) | FR2740973B1 (en) |
IS (1) | IS1880B (en) |
NO (1) | NO315495B1 (en) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6147084A (en) * | 1993-07-19 | 2000-11-14 | Toray Industries, Inc. | Brain cell protective agent |
US6187761B1 (en) * | 1996-08-12 | 2001-02-13 | Gist-Brocades B.V. | Production and use of compositions comprising high concentrations of vitamin B12 activity |
CN100376251C (en) * | 2003-05-07 | 2008-03-26 | 卫材R&D管理有限公司 | Freeze-dried preparation containing methylcobalamin and process for producing the same |
US9585908B1 (en) | 2010-11-08 | 2017-03-07 | Chromaceutical Advanced Technologies, Inc. | Collyrium composition and method of using same |
US9757354B2 (en) * | 2015-06-08 | 2017-09-12 | Regents Of The University Of Minnesota | Therapeutic formulations and methods |
EP4173618A1 (en) | 2021-10-29 | 2023-05-03 | Original Biomedicals Co., Ltd. | Composition for upper respiratory tract administration comprising a metal chelator and a cyanide antidote and method thereof |
US11925623B2 (en) | 2020-07-21 | 2024-03-12 | Regents Of The University Of Minnesota | Methods for the treatment of conditions related to hydrogen sulfide |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE788780A (en) * | 1971-09-21 | 1973-01-02 | Rolland Sa A | METHOD FOR THE DIAGNOSIS OF HYPERCYANURIA |
FR2534809B1 (en) * | 1982-10-26 | 1985-06-28 | Roussel Uclaf | DRUG COMBINATION CONTAINING, AS ACTIVE INGREDIENTS, A CENTRAL ANALGESIC AND VITAMIN B 12 OR A DERIVATIVE THEREOF |
-
1995
- 1995-11-15 FR FR9513512A patent/FR2740973B1/en not_active Expired - Lifetime
-
1996
- 1996-10-29 DK DK96117314T patent/DK0775485T3/en active
- 1996-10-29 ES ES96117314T patent/ES2171591T3/en not_active Expired - Lifetime
- 1996-10-29 EP EP96117314A patent/EP0775485B1/en not_active Expired - Lifetime
- 1996-10-29 DE DE69619767T patent/DE69619767T2/en not_active Expired - Lifetime
- 1996-11-08 AU AU71720/96A patent/AU720219B2/en not_active Expired
- 1996-11-14 NO NO19964825A patent/NO315495B1/en not_active IP Right Cessation
- 1996-11-14 IS IS4387A patent/IS1880B/en unknown
- 1996-11-14 US US08/748,790 patent/US5834448A/en not_active Expired - Lifetime
- 1996-11-15 JP JP31850496A patent/JP3699223B2/en not_active Expired - Lifetime
Non-Patent Citations (2)
Title |
---|
CA:72:103759 & JP 45002758 B1, Jan. 29, 1970. * |
CA:72:103759 JP 45002758 Jan. 29, 1970. |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6147084A (en) * | 1993-07-19 | 2000-11-14 | Toray Industries, Inc. | Brain cell protective agent |
US6187761B1 (en) * | 1996-08-12 | 2001-02-13 | Gist-Brocades B.V. | Production and use of compositions comprising high concentrations of vitamin B12 activity |
CN100376251C (en) * | 2003-05-07 | 2008-03-26 | 卫材R&D管理有限公司 | Freeze-dried preparation containing methylcobalamin and process for producing the same |
US9585908B1 (en) | 2010-11-08 | 2017-03-07 | Chromaceutical Advanced Technologies, Inc. | Collyrium composition and method of using same |
US9757354B2 (en) * | 2015-06-08 | 2017-09-12 | Regents Of The University Of Minnesota | Therapeutic formulations and methods |
US11925623B2 (en) | 2020-07-21 | 2024-03-12 | Regents Of The University Of Minnesota | Methods for the treatment of conditions related to hydrogen sulfide |
EP4173618A1 (en) | 2021-10-29 | 2023-05-03 | Original Biomedicals Co., Ltd. | Composition for upper respiratory tract administration comprising a metal chelator and a cyanide antidote and method thereof |
Also Published As
Publication number | Publication date |
---|---|
NO964825D0 (en) | 1996-11-14 |
JP3699223B2 (en) | 2005-09-28 |
EP0775485B1 (en) | 2002-03-13 |
JPH09136837A (en) | 1997-05-27 |
DE69619767T2 (en) | 2002-10-10 |
DK0775485T3 (en) | 2002-05-06 |
EP0775485A1 (en) | 1997-05-28 |
FR2740973B1 (en) | 1998-02-06 |
NO964825L (en) | 1997-05-16 |
IS4387A (en) | 1997-05-16 |
AU7172096A (en) | 1997-05-22 |
ES2171591T3 (en) | 2002-09-16 |
IS1880B (en) | 2003-08-15 |
NO315495B1 (en) | 2003-09-15 |
AU720219B2 (en) | 2000-05-25 |
DE69619767D1 (en) | 2002-04-18 |
FR2740973A1 (en) | 1997-05-16 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: MERCK PATENT GESELLSCHAFT MIT BESCHRANKTER HAFTUNG Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:POUCHOL, GERARD;BONHOMME, YVES;POULAIN, MARIE-LAURE;AND OTHERS;REEL/FRAME:008332/0705 Effective date: 19961111 |
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Free format text: PATENTED CASE |
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Free format text: PAYOR NUMBER ASSIGNED (ORIGINAL EVENT CODE: ASPN); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY |
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Year of fee payment: 4 |
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FPAY | Fee payment |
Year of fee payment: 8 |
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FPAY | Fee payment |
Year of fee payment: 12 |
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AS | Assignment |
Owner name: SERB, BELGIUM Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MERCK PATENT GMBH;REEL/FRAME:037256/0824 Effective date: 20151118 |